Study to Evaluate the Safety and Efficacy of the CiTop™ ExPander™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries

This study has been terminated.
(no interest to develop the product)
Sponsor:
Information provided by:
Ovalum
ClinicalTrials.gov Identifier:
NCT00733070
First received: August 10, 2008
Last updated: July 6, 2013
Last verified: July 2013
  Purpose

A multicenter multinational study to evaluate the safety and efficacy of the CiTop™ ExPander™ Guidewire for crossing chronic total occlusion in Coronary arteries.


Condition Intervention
Coronary Chronic Total Occlusion
Device: CiTop™ ExPander™ Guidewire

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Multinational Study to Evaluate the Safety and Efficacy of the CiTop™ ExPander™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries

Further study details as provided by Ovalum:

Primary Outcome Measures:
  • Angiographic documentation of placement of CiTop™ distal to occlusion with no device related major complications [ Time Frame: during procedure, 1day, 1week and 30 days post procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Successful stenting [ Time Frame: During procedure, Day1, Day7 and Day30 post procedure ] [ Designated as safety issue: Yes ]
  • Wire crossing duration [ Time Frame: during procedure ] [ Designated as safety issue: No ]
  • Fluoroscopy time [ Time Frame: during procedure ] [ Designated as safety issue: Yes ]
  • Amount of contrast [ Time Frame: during procedure ] [ Designated as safety issue: Yes ]
  • Maneuverability of the CiTop™ up to the occlusion [ Time Frame: during procedure ] [ Designated as safety issue: Yes ]
  • No mechanical damage to the device during [ Time Frame: during procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: August 2008
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: CiTop™ ExPander™ Guidewire
    Chronic Total Occlusion guidewire
  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Informed consent obtained prior to any trial activities.
  2. Patients, male or female between 21 and 80 years of age, with no significant co-morbidities (see exclusion criteria).
  3. Patient has an angiographic documented Chronic Total Occlusion showing distal TIMI flow 0 to 1.

Exclusion Criteria:

  1. Patient unable to give informed consent.
  2. Current participation in another study with any investigational drug or device.
  3. Factors making follow-up and/or repeat angiography difficult or unlikely.
  4. Contra-indication to emergency artery by pass surgery.
  5. Lack of surgical backup.
  6. Contra-indication to treatment with Aspirin, or Clopidogrel and/or Heparin.
  7. Lesion > 40mm in length (both calcified lesion and adjacent thrombus).
  8. Treated vessel referenced diameter less than 2.5 mm.
  9. Visualization of the distal lumen less than the Rentrop Classification Grade 2 collateralization.
  10. Non-visible entry point of target lesion.
  11. Totally occluded bypass graft as target vessel.
  12. Acute MI less than 1 week before procedure.
  13. Patient has significant LV dysfunction, 35% LVEF or less.
  14. Patient with cancer or other sever chronic disease with life expectance of 2 years.
  15. Patient has chronic renal failure with serum creatinine ≥2.
  16. Hemoglobin ≤11.
  17. Patient is known or suspected not to tolerate the contrast agent.
  18. Morbid Obesity (BMI > 40).
  19. Drug abuse or alcoholism.
  20. Patients under custodial care.
  21. Pregnant women or women with childbearing potential with a positive pregnancy test at the time of procedure.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733070

Locations
Germany
HELIOS Klinikum Wuppertal
Wuppertal, Germany, D-42117
South Africa
Sunward Park Hospital
Boksburg, South Africa
Sunninghill Hospital
Sunninghill, South Africa, 2157
Sponsors and Collaborators
Ovalum
  More Information

No publications provided

Responsible Party: Nathalie Gilat, Ovalum
ClinicalTrials.gov Identifier: NCT00733070     History of Changes
Other Study ID Numbers: OVC-003-00
Study First Received: August 10, 2008
Last Updated: July 6, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Ovalum:
CTO
Chronic Total Occlusion
Revascularization

ClinicalTrials.gov processed this record on April 16, 2014